Atlas FDA

ABBOTT PLUM A+INFUSION PUMP, MODEL 11971

FDA 510(k) clearance K011442 · decided 2001-06-05

Clearance details

K-number
K011442
Device name
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2001-05-10
Decision date
2001-06-05
Days to decision
26 days
Clearance type
Special
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's recall (Z-1071-2015)Hospira Inc.2015-02-23
Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are recall (Z-0204-2014)Hospira Inc.2013-11-14
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows recall (Z-0284-2014)Hospira Inc.2013-11-14
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps wer recall (Z-0624-2013)Hospira Inc.2012-12-31
Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethern recall (Z-0481-2013)Hospira Inc.2012-12-07
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps wer recall (Z-0009-2012)Hospira Inc.2011-10-04
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps wer recall (Z-3284-2011)Hospira Inc.2011-09-29
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps wer recall (Z-1644-2011)Hospira Inc.2011-03-14
Plum A+ v.10.3, list #s 11971-04-01, 11971-04-03, 11971-04-05, 11971-04-07, 11971-04-51; A recall (Z-0025-2010)Hospira Inc2009-10-06

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30